Are Food Allergen Thresholds on the (Far) Horizon?

Signaling potential movement on an issue that has bedeviled industry, FDA published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.” Undeclared major food allergens continue to be one of the two principal causes of reportable food incidents, typically leading to Class I recalls. As acknowledged in the notice, the “establishment of regulatory thresholds or action levels for major food allergens would help [FDA] determine whether, or what type of, enforcement action is appropriate when specific problems are identified.”

FDA’s notice suggests other ways that establishment of thresholds could be helpful (i.e., by helping to “establish a clear standard for evaluating claims in FALCPA petitions” for exemption from allergen declaration, and by helping industry “conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls” – actions that will be required under FSMA). However, the most immediate and tangible benefits could be realized in the context of enforcement. This point is more clearly recognized in FDA’s accompanying release (“If safe thresholds can be established, the FDA could more effectively determine the appropriate corrective action to unintentional allergen contamination issues…[and] better respond to situations where undeclared allergens are found in foods”). The release also recognizes that the absence of thresholds might be unnecessarily constraining consumer choice.

FDA’s notice hints at the “significant advances in both scientific tools and data resource related to food allergens” that have taken place in the six years since the agency’s Threshold Working Group issued a report summarizing its evaluation of approaches for establishing thresholds. The agency evidently felt the time was ripe to ask for data that will support its conduct of a quantitative risk assessment. The notice asks for comments (including data) on the following issues:

How should we define “an allergic response that poses a risk to human health?”

Which major food allergens are of greatest public health concern and what is the size of the at-risk population?

How should clinical dose distribution data be used when establishing regulatory thresholds for the major food allergens?

What approaches exist for using biological markers or other factors related to the severity of allergic responses in a threshold risk assessment?

What data and information exist on dietary exposure patterns for individuals on allergen avoidance diets?

What data or other information exist on current levels of exposure associated with the consumption of undeclared major food allergens in packaged foods?

What other information or data should we consider in establishing regulatory thresholds for major food allergens?

The scope of the above issues and the history of other risk assessments suggests that any risk assessment for establishing regulatory thresholds will take considerable time and effort to complete. Given the high stakes, this initiative appears worthy of strong industry support. Comments are due February 12.